MLSS Milestone Scientific Inc

Milestone Scientific Inc. (NYSE: MLSS), a leading developer of computerized drug delivery instruments that provide painless and precise injections, today provides a business update and reported financial results for the second quarter ended June 30, 2024.

Arjan Haverhals, CEO and President of Milestone Scientific, commented, “We are successfully advancing our reimbursement strategy for the CompuFlo® Epidural System, aimed at achieving nationwide coverage. Last month, we reached a significant milestone as we were granted a Medicare Part B Physician payment rate for the CompuFlo® Epidural System under the American Medical Association’s (AMA) technology-specific Category III CPT® code CPT0777T (real-time pressure-sensing epidural guidance system when used in conjunction with a primary ESI procedure). This favorable Medicare pricing for our CompuFlo® Epidural System was granted for multiple Jurisdictional Medicare Administrative Contractors (JMAC) regions, which include states such as Florida, Texas, Pennsylvania, New Jersey, Maryland, Colorado, Oklahoma, Louisiana, Arkansas, Mississippi, New Mexico, District of Columbia, and Delaware. We view this achievement as a transformative event for the Company as we advance our efforts to establish CompuFlo® technology as the standard of care for epidural procedures nationwide.”

“Immediately following the Medicare price assignment, we announced a strategic partnership with Axial Biologics to accelerate the adoption of our CompuFlo® Epidural System. This collaboration significantly extends our reach within the pain management market, leveraging Axial’s established relationships with clinicians in key states such as New Jersey, Texas, and Florida.”

Haverhals continued, "Within our dental division, U.S. e-commerce sales increased to $1.3 million in Q2 2024, compared to $1.2 million for the same period last year, as a result of our strategic decision to end the agreement with our previous distributor and instead channel sales through our online portal. This shift has enabled us to foster a closer, more direct relationship with our customers, as well as improve our margins. Specifically, gross margins increased to 76.1% in Q2 2024 from 65.0% in the same quarter last year. We expect domestic sales will steadily increase as we continue to promote our new e-commerce platform by reaching out directly to customers and patients through our renewed marketing campaigns. On the international front, we faced some temporary challenges related to the distributor’s freight forwarders, which have since been resolved. Additionally, our decision to pause sales in China impacted year-over-year comparisons. Nevertheless, we currently believe that international sales in the second half of this year will show improvement over both the second half of last year and first half of this year. We remain optimistic about the future and believe we have established a scalable, high-margin dental business that will continue to generate positive cash flow."

“In addition to our improved gross margins, we have taken steps to further streamline operations across the organization. Most notably, we reduced selling, general, and administrative expenses by over $1.1 million compared to the same period last year, further aligning us with our goal of achieving positive cash flow company-wide. With approximately $5.8 million in cash and cash equivalents at the end of the quarter, we are confident that we have sufficient capital to support our growth within both the dental and medical divisions.”

For the three months ended June 30, 2024, and 2023, revenues were approximately $1.9 million and $2.9 million, respectively. As of January 3, 2023, the Company launched an e-commerce platform, selling and shipping the STA Single Tooth Anesthesia System® (STA) and handpieces directly to end users, including dental offices and dental groups. The U.S. e-commerce revenue for the three months ended June 30, 2024, was approximately $1.3 million compared to $1.2 million for the three months ended June 30, 2023. The Company recorded no revenue from other U.S. distributors for the three months ended June 30, 2024 compared to approximately $214,000 for the three months ended June 30, 2023. The Company terminated all non-exclusive agreements with other distributors in the U.S. in September 2023. For the three months ended June 30, 2024, international revenue was approximately $490,000 a decrease of $710,000, compared to June 30, 2023. International sales decreased due to issues with freight forwarder carrier during the quarter. The Company recorded no revenue from China for the three months ended June 30, 2024 compared to approximately $270,000 for the three months ended June 30, 2023.Gross profit for the second quarter ended June 30, 2024, was $1.4 million, or 76% of revenue, versus $1.9 million, or 65% of revenue, for the second quarter ended June 30, 2023. The decrease in gross profit was due to higher margins in sales associated with the launch of the e-commerce platform offset by a decrease in international sales. Operating loss for the three months ended June 30, 2024, was approximately $(1.8) million versus approximately $(2.3) million for the second quarter ended June 30, 2023. Net income was approximately $0.2 million, or $0.00 per share for the three months ended June 30, 2024, versus net loss of $(1.3) million, or $(0.02) per share, for the comparable period in 2023. Net income for the three months ended June 30, 2024, included approximately $2.0 million, net of expenses, from the sale of New Jersey net operating losses (“NOL”).

For the six months ended June 30, 2024, and 2023, revenue was approximately $4.1 million and $5.5 million, respectively. The U.S. e-commerce and dental service revenue for the six months ended June 30, 2024 was approximately $2.7 million compared to $2.2 million at June 30, 2023. The Company terminated its remaining U.S. distributor in September 2023. The Company recorded no revenue from other U.S. distributors for the six months ended June 30, 2024 compared to approximately $432,000 for the six months ended June 30, 2023. For the six months ended June 30, 2024, international revenue was approximately $1.4 million, a decrease of $1.0 million, compared to June 30, 2023. International sales decreased due to issues with freight forwarders carrier during the quarter. The Company recorded no revenue from China for the six months ended June 30, 2024 compared to approximately $270,000 for the six months ended June 30, 2023. Gross profit for the first six months of 2024 was $3.1 million, or 75% of revenue, versus $3.8 million, or 69% of revenue, for the first six months of 2023. Operating loss for the first six months of 2024 was approximately $(3.2) million versus approximately $(3.6) million for the first six months of 2023. Net loss for the first six months of 2024 was $(1.2) million, or $(0.02) per share, versus net loss of $(3.5) million, or $(0.05) per share per share for the comparable period in 2023.

As of June 30, 2024, the Company had cash and cash equivalents of approximately $5.8 million and working capital of approximately $7.7 million.

Conference Call

Milestone Scientific’s executive management team will host a conference call on Thursday, August 15, 2024 at 8:30 AM Eastern Time to discuss the Company’s financial results for the second quarter ended June 30, 2024, as well as the Company’s corporate progress and other developments.

The conference call will be available via telephone by dialing toll free 888-506-0062 for U.S. callers or +1 973-528-0011 for international callers and by entering the access code: 959238. A webcast and replay of the call may be accessed at Webcast URL: https://www.webcaster4.com/Webcast/Page/2306/51045.

An audio replay of the call will be available through Thursday, August 29, 2024, and can be accessed by dialing 877-481-4010 for U.S. callers or +1 919-882-2331 for international callers and by entering the access code: 51045.

About Milestone Scientific Inc.Milestone Scientific Inc. (MLSS), a technology focused medical research and development company that patents, designs and develops innovative injection technologies and instruments for medical and dental applications. Milestone Scientific’s computer-controlled systems are designed to make injections precise, efficient and increase the overall patient comfort and safety. Their proprietary DPS Dynamic Pressure Sensing Technology® instruments is the platform to advance the development of next-generation devices, regulating flow rate and monitoring pressure from the tip of the needle, through platform extensions of subcutaneous drug delivery, including local anesthetic. To learn more, view the MLSS brand video or visit milestonescientific.com.

Safe Harbor Statement

This press release contains forward-looking statements regarding the timing and financial impact of Milestone's ability to implement its business plan, expected revenues, timing of regulatory approvals and future success. These statements involve a number of risks and uncertainties and are based on assumptions involving judgments with respect to future economic, competitive and market conditions, future business decisions and regulatory developments, all of which are difficult or impossible to predict accurately and many of which are beyond Milestone's control. Some of the important factors that could cause actual results to differ materially from those indicated by the forward-looking statements are general economic conditions, failure to achieve expected revenue growth, changes in our operating expenses, adverse patent rulings, FDA or legal developments, competitive pressures, changes in customer and market requirements and standards, and the risk factors detailed from time to time in Milestone's periodic filings with the Securities and Exchange Commission, including without limitation, Milestone's Annual Report for the year ended December 31, 2022. The forward-looking statements in this press release are based upon management's reasonable belief as of the date hereof. Milestone undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

Contact:Crescendo Communications, LLCEmail: mlss@crescendo-ir.comTel: 212-671-1020

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MILESTONE SCIENTIFIC AND SUBSIDIARIESCONDENSED CONSOLIDATED BALANCE SHEETS(UNAUDITED)
	June 30, 2024					December 31, 2023
ASSETS	(Unaudited)
Current assets:
Cash and cash equivalents		$	5,752,106			$	2,977,713
Marketable securities			-				2,976,573
Accounts receivable, net of allowance for credit losses of $10,000, respectively			386,836				312,664
Prepaid expenses and other current assets			774,603				517,785
Inventories			3,329,101				2,638,186
Advances on contracts			1,250,953				1,371,548
Total current assets			11,493,599				10,794,469
Furniture, fixtures and equipment, net			12,989				10,024
Intangibles, net			162,105				178,636
Right of use assets finance lease			4,673				8,998
Right of use assets operating lease			307,724				355,235
Other assets			24,150				24,150
Total assets		$	12,005,240			$	11,371,512
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	1,403,137			$	689,604
Accounts payable, related party			814,829				410,512
Accrued expenses and other payables			1,070,276				1,511,717
Accrued expenses, related party			208,682				137,189
Accrued Liabilities noncontrolling interest			214,000				214,000
Current portion of finance lease liabilities			5,683				10,264
Current portion of operating lease liabilities			109,706				103,427
Total current liabilities			3,826,313				3,076,713
Non-current portion of finance lease liabilities			-				434
Non-current portion of operating lease liabilities			225,050				281,853
Total liabilities		$	4,051,363			$	3,359,000
Commitments and contingencies
Stockholders’ equity
Common stock, par value $0.001; authorized 100,000,000 shares; 77,227,714 shares issued and 77,194,381 shares outstanding as of June 30, 2024; 75,881,840 shares issued and 75,848,507 shares outstanding as of December 31, 2023;			77,228				75,881
Additional paid in capital			133,344,565				132,187,656
Accumulated deficit			(124,556,400	)			(123,339,509	)
Treasury stock, at cost, 33,333 shares			(911,516	)			(911,516	)
Total Milestone Scientific, Inc. stockholders' equity			7,953,877				8,012,512
Total liabilities and stockholders’ equity		$	12,005,240			$	11,371,512

MILESTONE SCIENTIFIC AND SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(UNAUDITED)
	For the three months ended June 30, 2024					For the three months ended June 30, 2023				For the six months ended June 30, 2024				For the six months ended June 30, 2023
Product sales, net		$	1,853,764			$	2,909,966			$	4,102,609			$	5,507,564
Cost of products sold			442,560				1,019,907				1,015,302				1,728,882
Gross profit			1,411,204				1,890,059				3,087,307				3,778,682
Selling, general and administrative expenses			2,868,182				3,937,281				5,903,458				7,011,012
Research and development expenses			314,968				213,647				409,179				353,994
Depreciation and amortization expense			8,477				16,681				20,161				33,902
Total operating expenses			3,191,627				4,167,609				6,332,798				7,398,908
Loss from operations			(1,780,423	)			(2,277,550	)			(3,245,491	)			(3,620,226	)
Interest income (expense)			20,966				48,722				45,505				72,067
Gain on sale of net operating losses			1,983,095				-				1,983,095				-
Loss before provision for income taxes			223,638				(2,228,828	)			(1,216,891	)			(3,548,159	)
Net income (loss)			223,638				(2,228,828	)			(1,216,891	)			(3,548,159	)
Net (loss) attributable to noncontrolling interests		$	-			$	(12,511	)		$	-			$	(24,176	)
Net income (loss) attributable to Milestone Scientific Inc.		$	223,638			$	(2,216,317	)		$	(1,216,891	)		$	(3,523,983	)
Net income (loss) per share applicable to common stockholders—
Basic and Diluted			0.00				(0.03	)			(0.02	)			(0.05	)
Weighted average shares outstanding and to be issued—
Basic			79,966,833				72,333,656				80,412,397				72,048,223
Diluted			79,967,086				72,333,656				80,412,397				72,048,223